Multinational landscape of health app policy: toward regulatory consensus on digital health

Due to its enormous capacity for benefit, harm, and cost, health care is among the most tightly regulated industries in the world. But with the rise of smartphones, an explosion of direct-to-consumer mobile health applications has challenged the role of centralized gatekeepers. As interest in health apps continue to climb, national regulatory bodies have turned their attention toward strategies to protect consumers from apps that mine and sell health data, recommend unsafe practices, or simply do not work as advertised. To characterize the current state and outlook of these efforts, Essen and colleagues map the nascent landscape of national health app policies and raise several considerations for cross-border collaboration. Strategies to increase transparency, organize app marketplaces, and monitor existing apps are needed to ensure that the global wave of new digital health tools fulfills its promise to improve health at scale.

Automated summary

The rise of mobile health applications challenges the role of centralized gatekeepers in the highly regulated health care industry. National regulatory bodies are now focusing on strategies to protect consumers from unsafe apps, and to ensure the transparency and effectiveness of the growing market of health apps. Cross-border collaboration is also needed to address these challenges and maximize the potential of digital health tools.